Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
12

Summary

Conditions
  • Electrical Impedance Tomography
  • Magnetic Resonance Imaging
  • Obesity
  • Obesity Hypoventilation Syndrome
  • Pulmonary Atelectasis
  • Respiratory Mechanics
  • Trans-Thoracic Echocardiography
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: 35 patients will be enrolled in this study. The study is divided in two phases: the first phase will evaluate the PEEP in 12 consecutive obese subjects and 6 healthy volunteers using Trans-thoracic echocardiography (TTE) and Electrical Impedance Tomography (EIT). The second phase will evaluate the PEEP in the other 12 consecutive obese subjects and 5 healthy volunteers using Magnetic Resonance Imaging (MRI).Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

Obese subjects are prone to develop respiratory insufficiency when requiring mechanical ventilation. Atelectasis is the primary responsible for respiratory insufficiency and impossibility to wean obese patients from respiratory support. The investigators do believe that the respiratory system derang...

Obese subjects are prone to develop respiratory insufficiency when requiring mechanical ventilation. Atelectasis is the primary responsible for respiratory insufficiency and impossibility to wean obese patients from respiratory support. The investigators do believe that the respiratory system derangements observed in the previous study during the critical illness are already present, although in lower severity, in the obese patients in their basal condition. This study will help to understand the standard cardiac and respiratory function of an obese non critically ill subject to better target the therapies during the management of the critical illness to reestablish the homeostasis of the system: The investigator's hypotheses are: To demonstrate if morbidly obese patients show atelectasis at spontaneous breathing in the supine position and whether the increase in lung volume following PEEP titration is due to alveolar recruitment rather than overdistention. To measure regional variations in ventilation/perfusion coupling at different ventilator settings To investigate the role of diaphragm position in the development/treatment of respiratory insufficiency due to increased pleural pressure To test if reopening of lung atelectasis through the application o a recruitment maneuver and titrated PEEP level would lead to an improvement in right heart function. To assess pulmonary circulation at different levels of PEEP.

Tracking Information

NCT #
NCT02523352
Collaborators
Not Provided
Investigators
Principal Investigator: Robert Kacmarek, RRT, PhD Massachussets General Hospital Principal Investigator: Lorenzo Berra, MD Massachusetts General Hospital